Intuitive Surgical, Inc. 2022-05-04 Health serious FDA
Health · FDA · Recall #FDA-Z-0999-2022
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45… Recall
Issued May 4, 2022 · Intuitive Surgical, Inc.
In May 2022, Intuitive Surgical, Inc. recalled the da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.
What you should do
- 1 Stop using da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Intuitive Surgical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Intuitive Surgical, Inc.
- Category
- Health
- Recall date
- May 4, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, K
- Recall number
- FDA-Z-0999-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Intuitive Surgical, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.